Incidence and consequence of major bleeding in primary percutaneous intervention for ST-elevation myocardial infarction in the era of radial access: an analysis of the international randomized Acute myocardial infarction Treated with primary angioplasty and intravenous enoxaparin Or unfractionated heparin to Lower ischemic and bleeding events at short- and Long-term follow-up trial

• Published in: The American heart journal Vol. 170; no. 4; pp. 778 - 786
• Main Authors: Pellaton, Cyril, MD, Cayla, Guillaume, MD, PhD, Silvain, Johanne, MD, PhD, Zeymer, Uwe, MD, PhD, Cohen, Marc, MD, Goldstein, Patrick, MD, Huber, Kurt, MD, PhD, Pollack, Charles, MD, Kerneis, Mathieu, MD, Collet, Jean-Philippe, MD, PhD, Vicaut, Eric, MD, PhD, Montalescot, Gilles, MD, PhD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.10.2015; Elsevier Limited; Elsevier
• Subjects: Acute coronary syndromes; Aged; Angioplasty; Angioplasty, Balloon, Coronary - adverse effects; Angioplasty, Balloon, Coronary - methods; Anticoagulants; Anticoagulants - administration & dosage; Anticoagulants - adverse effects; Blood pressure; Cardiac Catheterization - adverse effects; Cardiac Catheterization - methods; Cardiology and cardiovascular system; Cardiovascular; Drug dosages; Electrocardiography; Enoxaparin - administration & dosage; Enoxaparin - adverse effects; Europe - epidemiology; Female; Follow-Up Studies; Heart attacks; Heparin - administration & dosage; Heparin - adverse effects; Human health and pathology; Humans; Incidence; Injections, Intravenous; Life Sciences; Male; Mortality; Myocardial Infarction - drug therapy; Myocardial Infarction - surgery; Percutaneous Coronary Intervention - adverse effects; Percutaneous Coronary Intervention - methods; Postoperative Hemorrhage - chemically induced; Postoperative Hemorrhage - epidemiology; Radial Artery; Time Factors; United States - epidemiology; United States; Europe
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2015.05.021

Aims The aims of the study are to compare the outcome with and without major bleeding and to identify the independent correlates of major bleeding complications and mortality in patients described in the ATOLL study. Methods The ATOLL study included 910 patients randomly assigned to either 0.5 mg/kg intravenous enoxaparin or unfractionated heparin before primary percutaneous coronary intervention. Incidence of major bleeding and ischemic end points was assessed at 1 month, and mortality, at 1 and 6 months. Patients with and without major bleeding complication were compared. A multivariate model of bleeding complications at 1 month and mortality at 6 months was realized. Intention-to-treat and per-protocol analyses were performed. Results The most frequent bleeding site appears to be the gastrointestinal tract. Age >75 years, cardiac arrest, and the use of insulin or >1 heparin emerged as independent correlates of major bleeding at 1 month. Patients presenting with major bleeding had significantly higher rates of adverse ischemic complications. Mortality at 6 months was higher in bleeders. Major bleeding was found to be one of the independent correlates of 6-month mortality. The addition or mixing of several anticoagulant drugs was an independent factor of major bleeding despite the predominant use of radial access. Conclusions This study shows that major bleeding is independently associated with poor outcome, increasing ischemic events, and mortality in primary percutaneous coronary intervention performed mostly with radial access.